Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

May 10, 2023 updated by: Oskar Nelzén, University Hospital, Linkoeping

Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D

200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58185
        • University Hospital Linköping
      • Norrköping, Östergötland, Sweden, 60379
        • Vrinnevisjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Insufficient great saphenous vein
  • Possible to treat with both radiofrequency ablation and high ligation/stripping
  • Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6

Exclusion Criteria:

  • Previous intervention in the affected leg
  • Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
  • Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min
  • Patient that is not able to perform plethysmography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiofrequency ablation
Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.
Procedure: Radiofrequency ablation
Device: Radiofrequency ablation catheter
Other Names:
  • Covidien ClosureFast Catheter (7cm)
Procedure: Tumescent anesthesia
Active Comparator: High ligation/stripping
Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.
Procedure: High ligation/stripping
Other Names:
  • Open surgery
Procedure: General anesthesia
Device: Vein stripping catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treated veins with recanalization using duplex.
Time Frame: 5 years
Flow detected by duplex at the site of the treated vein.
5 years
Number of treated limbs with neovascularization using duplex and/or plethysmography.
Time Frame: 5 years
5 years
Prediction of treatment outcome using plethysmography with superficial shut-down.
Time Frame: 1 month postoperatively
If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VCSS score
Time Frame: 5 years
The score of standardized examination protocol VCSS.
5 years
AVVQ score
Time Frame: 5 years
The score of disease specific questionnaire AVVQ
5 years
EQ-5D score
Time Frame: 5 years
The score of EQ-5D questionnaire
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Study Chair: Helene Zachrisson, Associate Professor, MD, Linkoeping University
  • Principal Investigator: Oskar Nelzén, MD, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

November 25, 2021

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Varicerstudien

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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